Recently, the Myanmar Ministry of Health’s Food and Drug Administration (MFDA) published a list of medical devices, MRI machines, CT scanners, and X-ray machines that are exempt from obtaining an Import Recommendation (IR) prior to importation.
The Myanmar Ministry of Health’s Food and Drug Administration (MFDA) oversees the safety and quality of medical devices and pharmaceutical drugs within the country. The “National Drug Law (1992)” is currently the only legislation available for medical goods, and there are no specific regulations pertaining to medical devices.
However, imported medical devices must obtain an Import Recommendation (IR) from the Medical Device Control Division of the MFDA and a Trade Permit from the Ministry of Trade and Commerce, which is often difficult due to complicated administrative requirements and lengthy processing times.
Recently, the Health Authority published a list of medical devices, MRI machines, CT scanners, and X-ray machines that are exempt from obtaining an Import Recommendation (IR) prior to importation.
List of Exempt Medical Devices
1. Agar/Culture Media
2. Adhesive Traction Kit
3. Body Composition Monitor
4. Binomag/ Binocular Loupes
5. Blood Bag Tube Sealer
6. ECG Paper
7. General Laboratory Equipment
8. Hot Air Oven
9. Lubricant or Gel Equipment
10. Medical Devices that are intended for Educational Purposes & Research Use Only
12. Pneumatic Walker
13. Plasma Extractor
14. Reverse Osmosis System for Hemodialysis Machines
16. Spare parts that are not accessories of medical devices
17. Sphygmomanometer (BP cuff manual)
18. Surgical Gowns
19. Blood Collection Tube (Glass Tubes)
The standards and conformance initiatives of the ASEAN region have influenced, and continued to drive change, in the policies on standards in Myanmar. As such, the MFDA has drafted the Law on Medical Devices according to the ASEAN Medical Device Directive (AMDD). The drafting process was expected to be completed at the end of 2016, followed by the drafting of regulations for implementation and the development of a digital and easily accessible medical device registration list. The ratification and full implementation of the AMDD is expected to be complete by 2020. In the meantime, the above additional list of exempt medical devices is likely to streamline the importation procedures of foreign-owned medical products in the country, and will significantly contribute to the growth of Myanmar’s emerging medical device market.